It’s understandable that the COVID-19 pandemic has dominated healthcare news and education over the past year. But in case you missed news about advances in other diseases, you will find this year’s issue of Hot Topics in Primary Care interesting and practice changing. Learn more as you read and watch the videos about the following articles:

• Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors

  

• Decision Points in the Management of Patients with Diabetic Kidney Disease
• Improving Shingles Vaccination Rates in Family Medicine
• National Asthma Education and Prevention Program 2020 Guidelines: What’s Important for Primary Care
• New Perspectives in COPD Management
• Obesity 2021: Current Clinical Management of a Chronic, Serious Disease
• Primary Prevention of CVD with Aspirin: Benefits vs Risks
• Screening for Autoantibodies in Type 1 Diabetes: A Call to Action
• The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient
• Use of SGLT-2 Inhibitors in Patients with Chronic Kidney Disease
• Utilizing CGM Ambulatory Glucose Profiles to Optimize Diabetes Management

This supplement offers the opportunity to earn a total of 6 CME credits. Credit is awarded for successful completion of the online evaluation after reading the article. The links can be found within the supplement on the first page of each article that offers the credits. 

Click here to read Hot Topics in Primary Care 2021

This supplement to The Journal of Family Practice was sponsored by the Primary Care Education Consortium and Primary Care Metabolic Group.
Check out these short video segments, which were prepared by the supplement authors and summarize the individual articles. 
By clicking each article title above the videos below you will be directed to the individual article within the supplement.

Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors, Timothy Reid, MD

Decision Points in the Management of Patients with Diabetic Kidney Disease, Matthew R. Weir, MD

Improving Shingles Vaccination Rates in Family Medicine, Jeffrey S. Luther, MD

National Asthma Education and Prevention Program 2020 Guidelines: What’s Important for Primary Care, Joel Solis, MD

New Perspectives in COPD Management, Barbara Yawn, MD, Msc, FAAFP

Obesity 2021: Current Clinical Management of a Chronic, Serious Disease, Robert Kushner, DO

Primary Prevention of CVD with Aspirin: Benefits vs Risks, Steven M. Weisman, PhD

Screening for Autoantibodies in Type 1 Diabetes: A Call to Action, Anne Peters, MD

The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient, Joseph L. Lillo, DO, FNLA, FAPCR, CPI

Use of SGLT-2 Inhibitors in Patients with Chronic Kidney Disease, Amy Mottl, MD, MPH, FASN

Utilizing CGM Ambulatory Glucose Profiles to Optimize Diabetes Management, Eden Miller, DO

It’s understandable that the COVID-19 pandemic has dominated healthcare news and education over the past year. But in case you missed news about advances in other diseases, you will find this year’s issue of Hot Topics in Primary Care interesting and practice changing. Learn more as you read and watch the videos about the following articles:

• Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors

  

• Decision Points in the Management of Patients with Diabetic Kidney Disease
• Improving Shingles Vaccination Rates in Family Medicine
• National Asthma Education and Prevention Program 2020 Guidelines: What’s Important for Primary Care
• New Perspectives in COPD Management
• Obesity 2021: Current Clinical Management of a Chronic, Serious Disease
• Primary Prevention of CVD with Aspirin: Benefits vs Risks
• Screening for Autoantibodies in Type 1 Diabetes: A Call to Action
• The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient
• Use of SGLT-2 Inhibitors in Patients with Chronic Kidney Disease
• Utilizing CGM Ambulatory Glucose Profiles to Optimize Diabetes Management

This supplement offers the opportunity to earn a total of 6 CME credits. Credit is awarded for successful completion of the online evaluation after reading the article. The links can be found within the supplement on the first page of each article that offers the credits. 

Click here to read Hot Topics in Primary Care 2021

This supplement to The Journal of Family Practice was sponsored by the Primary Care Education Consortium and Primary Care Metabolic Group.
Check out these short video segments, which were prepared by the supplement authors and summarize the individual articles. 
By clicking each article title above the videos below you will be directed to the individual article within the supplement.

Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors, Timothy Reid, MD

Decision Points in the Management of Patients with Diabetic Kidney Disease, Matthew R. Weir, MD

Improving Shingles Vaccination Rates in Family Medicine, Jeffrey S. Luther, MD

National Asthma Education and Prevention Program 2020 Guidelines: What’s Important for Primary Care, Joel Solis, MD

New Perspectives in COPD Management, Barbara Yawn, MD, Msc, FAAFP

Obesity 2021: Current Clinical Management of a Chronic, Serious Disease, Robert Kushner, DO

Primary Prevention of CVD with Aspirin: Benefits vs Risks, Steven M. Weisman, PhD

Screening for Autoantibodies in Type 1 Diabetes: A Call to Action, Anne Peters, MD

The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient, Joseph L. Lillo, DO, FNLA, FAPCR, CPI

Use of SGLT-2 Inhibitors in Patients with Chronic Kidney Disease, Amy Mottl, MD, MPH, FASN

Utilizing CGM Ambulatory Glucose Profiles to Optimize Diabetes Management, Eden Miller, DO

It’s understandable that the COVID-19 pandemic has dominated healthcare news and education over the past year. But in case you missed news about advances in other diseases, you will find this year’s issue of Hot Topics in Primary Care interesting and practice changing. Learn more as you read and watch the videos about the following articles:

• Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors

  

• Decision Points in the Management of Patients with Diabetic Kidney Disease
• Improving Shingles Vaccination Rates in Family Medicine
• National Asthma Education and Prevention Program 2020 Guidelines: What’s Important for Primary Care
• New Perspectives in COPD Management
• Obesity 2021: Current Clinical Management of a Chronic, Serious Disease
• Primary Prevention of CVD with Aspirin: Benefits vs Risks
• Screening for Autoantibodies in Type 1 Diabetes: A Call to Action
• The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient
• Use of SGLT-2 Inhibitors in Patients with Chronic Kidney Disease
• Utilizing CGM Ambulatory Glucose Profiles to Optimize Diabetes Management

This supplement offers the opportunity to earn a total of 6 CME credits. Credit is awarded for successful completion of the online evaluation after reading the article. The links can be found within the supplement on the first page of each article that offers the credits. 

Click here to read Hot Topics in Primary Care 2021

This supplement to The Journal of Family Practice was sponsored by the Primary Care Education Consortium and Primary Care Metabolic Group.
Check out these short video segments, which were prepared by the supplement authors and summarize the individual articles. 
By clicking each article title above the videos below you will be directed to the individual article within the supplement.

Cardiometabolic Risk Reduction: A Review of Clinical Guidelines and the Role of SGLT-2 Inhibitors, Timothy Reid, MD

Decision Points in the Management of Patients with Diabetic Kidney Disease, Matthew R. Weir, MD

Improving Shingles Vaccination Rates in Family Medicine, Jeffrey S. Luther, MD

National Asthma Education and Prevention Program 2020 Guidelines: What’s Important for Primary Care, Joel Solis, MD

New Perspectives in COPD Management, Barbara Yawn, MD, Msc, FAAFP

Obesity 2021: Current Clinical Management of a Chronic, Serious Disease, Robert Kushner, DO

Primary Prevention of CVD with Aspirin: Benefits vs Risks, Steven M. Weisman, PhD

Screening for Autoantibodies in Type 1 Diabetes: A Call to Action, Anne Peters, MD

The Challenge: Finding the Most Appropriate Statin and Dose for Each Patient, Joseph L. Lillo, DO, FNLA, FAPCR, CPI

Use of SGLT-2 Inhibitors in Patients with Chronic Kidney Disease, Amy Mottl, MD, MPH, FASN

Utilizing CGM Ambulatory Glucose Profiles to Optimize Diabetes Management, Eden Miller, DO

Hospital medicine procedure services have proliferated in recent years, driven by multiple synergistic factors, including an interest in improving hospital throughput, bolstering resident education, and ensuring full-spectrum practice for hospitalists. These services have become established and have demonstrated their capabilities, further catalyzed by emerging interest—and expertise—in point-of-care ultrasonography by hospitalists.

Most hospital medicine procedure services (HMPSs) focus on performing ultrasound-assisted procedures at bedside, providing purported advantages in convenience, cost, and potentially timing when compared to services performed by interventional radiology. The scope of procedures performed by HPMSs reflects the populations cared for by hospitalists, including paracentesis, thoracentesis, central venous catheter placement, lumbar puncture and, more recently, pigtail chest tube placement.^1,2 Fitting with the early development of HMPSs, initial reports regarding these services centered on optimal development of services and emphasized the question, “Are hospital medicine procedure services able to do [procedure x] as safely as radiology or the primary team?”²

Ensuring safety and quality is fundamental to implementing new workflows; however, it is now clear that HMPSs provide high-quality, safe, patient-centered bedside procedures; these services are no longer novel.³ As HMPSs mature, so too must their evaluation, research, and scholarship. It is no longer enough to document that a HMPS can perform procedures as well as interventional radiology or a standard hospital medicine care team—instead, we must identify how these services affect patient outcomes, improve education, add value, and influence the overall process of care in the hospital.

In this issue of the Journal of Hospital Medicine, Ritter and colleagues⁴ describe an important first step in this maturing field by evaluating how a HMPS affects process outcomes in the context of paracentesis. The faster time from admission to paracentesis observed in the HMPS population compared with radiology services has important implications for patient satisfaction (symptom relief) and morbidity and mortality (time to peritonitis diagnosis). Ritter et al also demonstrated shorter length of stay (LOS) among patients who had paracenteses performed by the HMPS compared with the radiology service; this finding is consistent with previous studies that, while not evaluating a HMPS per se, demonstrated shorter LOS with bedside paracentesis. While there were some limitations, such as the findings representing a single-site experience and group differences that necessitated assessment of multiple confounders (some of which may remain unknown), the authors’ efforts to shift focus toward patient and high-value care outcomes should be applauded.

The evaluation of HMPSs has reached an inflection point. The field must now focus on assessing outcomes. Does the appropriateness of procedures improve when those with internal medicine training are performing the procedures rather than radiologists, who have more focused procedural knowledge but less general medical training? What procedures are not or should not be performed by HMPSs? What does the shift of procedures to HMPSs do to the flow of patients and procedures in interventional radiology, and do other patients indirectly benefit? How should hospital medicine groups and hospitals account for lower work relative value unit productivity of HMPSs compared with other traditional rounding services? In what ways do HMPSs provide cost-effective care compared with alternatives? There has been limited evaluation of cost-savings realized when performing paracentesis at the bedside as opposed to in the interventional radiology suite.⁵

Additionally, most HMPSs are staffed by a small number of hospitalists within a group. It is unclear how a HMPS will affect general hospitalist procedural competence, and whether that even matters. Should we still expect every hospitalist to be able to perform procedures, or are HMPSs a step in the evolution of subspecialties in hospital medicine? Such subspecialties exist already, including perioperative medicine and transitional care specialists.

Now that more HMPSs have been established, the next step in their evolution must go beyond feasibility and safety assessments and toward evaluation of their effectiveness. It has become clear that HMPSs can perform procedures safely, but what can they do better?

Hospital medicine procedure services have proliferated in recent years, driven by multiple synergistic factors, including an interest in improving hospital throughput, bolstering resident education, and ensuring full-spectrum practice for hospitalists. These services have become established and have demonstrated their capabilities, further catalyzed by emerging interest—and expertise—in point-of-care ultrasonography by hospitalists.

Most hospital medicine procedure services (HMPSs) focus on performing ultrasound-assisted procedures at bedside, providing purported advantages in convenience, cost, and potentially timing when compared to services performed by interventional radiology. The scope of procedures performed by HPMSs reflects the populations cared for by hospitalists, including paracentesis, thoracentesis, central venous catheter placement, lumbar puncture and, more recently, pigtail chest tube placement.^1,2 Fitting with the early development of HMPSs, initial reports regarding these services centered on optimal development of services and emphasized the question, “Are hospital medicine procedure services able to do [procedure x] as safely as radiology or the primary team?”²

Ensuring safety and quality is fundamental to implementing new workflows; however, it is now clear that HMPSs provide high-quality, safe, patient-centered bedside procedures; these services are no longer novel.³ As HMPSs mature, so too must their evaluation, research, and scholarship. It is no longer enough to document that a HMPS can perform procedures as well as interventional radiology or a standard hospital medicine care team—instead, we must identify how these services affect patient outcomes, improve education, add value, and influence the overall process of care in the hospital.

In this issue of the Journal of Hospital Medicine, Ritter and colleagues⁴ describe an important first step in this maturing field by evaluating how a HMPS affects process outcomes in the context of paracentesis. The faster time from admission to paracentesis observed in the HMPS population compared with radiology services has important implications for patient satisfaction (symptom relief) and morbidity and mortality (time to peritonitis diagnosis). Ritter et al also demonstrated shorter length of stay (LOS) among patients who had paracenteses performed by the HMPS compared with the radiology service; this finding is consistent with previous studies that, while not evaluating a HMPS per se, demonstrated shorter LOS with bedside paracentesis. While there were some limitations, such as the findings representing a single-site experience and group differences that necessitated assessment of multiple confounders (some of which may remain unknown), the authors’ efforts to shift focus toward patient and high-value care outcomes should be applauded.

The evaluation of HMPSs has reached an inflection point. The field must now focus on assessing outcomes. Does the appropriateness of procedures improve when those with internal medicine training are performing the procedures rather than radiologists, who have more focused procedural knowledge but less general medical training? What procedures are not or should not be performed by HMPSs? What does the shift of procedures to HMPSs do to the flow of patients and procedures in interventional radiology, and do other patients indirectly benefit? How should hospital medicine groups and hospitals account for lower work relative value unit productivity of HMPSs compared with other traditional rounding services? In what ways do HMPSs provide cost-effective care compared with alternatives? There has been limited evaluation of cost-savings realized when performing paracentesis at the bedside as opposed to in the interventional radiology suite.⁵

Additionally, most HMPSs are staffed by a small number of hospitalists within a group. It is unclear how a HMPS will affect general hospitalist procedural competence, and whether that even matters. Should we still expect every hospitalist to be able to perform procedures, or are HMPSs a step in the evolution of subspecialties in hospital medicine? Such subspecialties exist already, including perioperative medicine and transitional care specialists.

Now that more HMPSs have been established, the next step in their evolution must go beyond feasibility and safety assessments and toward evaluation of their effectiveness. It has become clear that HMPSs can perform procedures safely, but what can they do better?

Hospital medicine procedure services have proliferated in recent years, driven by multiple synergistic factors, including an interest in improving hospital throughput, bolstering resident education, and ensuring full-spectrum practice for hospitalists. These services have become established and have demonstrated their capabilities, further catalyzed by emerging interest—and expertise—in point-of-care ultrasonography by hospitalists.

Most hospital medicine procedure services (HMPSs) focus on performing ultrasound-assisted procedures at bedside, providing purported advantages in convenience, cost, and potentially timing when compared to services performed by interventional radiology. The scope of procedures performed by HPMSs reflects the populations cared for by hospitalists, including paracentesis, thoracentesis, central venous catheter placement, lumbar puncture and, more recently, pigtail chest tube placement.^1,2 Fitting with the early development of HMPSs, initial reports regarding these services centered on optimal development of services and emphasized the question, “Are hospital medicine procedure services able to do [procedure x] as safely as radiology or the primary team?”²

Ensuring safety and quality is fundamental to implementing new workflows; however, it is now clear that HMPSs provide high-quality, safe, patient-centered bedside procedures; these services are no longer novel.³ As HMPSs mature, so too must their evaluation, research, and scholarship. It is no longer enough to document that a HMPS can perform procedures as well as interventional radiology or a standard hospital medicine care team—instead, we must identify how these services affect patient outcomes, improve education, add value, and influence the overall process of care in the hospital.

In this issue of the Journal of Hospital Medicine, Ritter and colleagues⁴ describe an important first step in this maturing field by evaluating how a HMPS affects process outcomes in the context of paracentesis. The faster time from admission to paracentesis observed in the HMPS population compared with radiology services has important implications for patient satisfaction (symptom relief) and morbidity and mortality (time to peritonitis diagnosis). Ritter et al also demonstrated shorter length of stay (LOS) among patients who had paracenteses performed by the HMPS compared with the radiology service; this finding is consistent with previous studies that, while not evaluating a HMPS per se, demonstrated shorter LOS with bedside paracentesis. While there were some limitations, such as the findings representing a single-site experience and group differences that necessitated assessment of multiple confounders (some of which may remain unknown), the authors’ efforts to shift focus toward patient and high-value care outcomes should be applauded.

The evaluation of HMPSs has reached an inflection point. The field must now focus on assessing outcomes. Does the appropriateness of procedures improve when those with internal medicine training are performing the procedures rather than radiologists, who have more focused procedural knowledge but less general medical training? What procedures are not or should not be performed by HMPSs? What does the shift of procedures to HMPSs do to the flow of patients and procedures in interventional radiology, and do other patients indirectly benefit? How should hospital medicine groups and hospitals account for lower work relative value unit productivity of HMPSs compared with other traditional rounding services? In what ways do HMPSs provide cost-effective care compared with alternatives? There has been limited evaluation of cost-savings realized when performing paracentesis at the bedside as opposed to in the interventional radiology suite.⁵

Additionally, most HMPSs are staffed by a small number of hospitalists within a group. It is unclear how a HMPS will affect general hospitalist procedural competence, and whether that even matters. Should we still expect every hospitalist to be able to perform procedures, or are HMPSs a step in the evolution of subspecialties in hospital medicine? Such subspecialties exist already, including perioperative medicine and transitional care specialists.

Now that more HMPSs have been established, the next step in their evolution must go beyond feasibility and safety assessments and toward evaluation of their effectiveness. It has become clear that HMPSs can perform procedures safely, but what can they do better?

Throughout North America, hospitalizations and deaths due to SARS-CoV-2 have fallen substantially due to the rapid roll-out of COVID-19 vaccines. Despite this monumental success, however, transmission of the virus will unfortunately persist for the foreseeable future due to a variety of factors, including incomplete population vaccination, emergence of variants, and increased exposures as social and economic activity return to normal.¹ Therefore, it is of critical importance to continue to track the burden of COVID-19 by region. Specifically, the incidence of hospitalizations due to COVID-19 will be a key metric, as highlighted by Tsai et al² in this issue of the Journal of Hospital Medicine.

Tsai et al² explored the challenge of accurately determining the burden of hospitalization due to COVID-19, focusing on the potential for misclassification leading to overestimations. They rigorously evaluated the proportion of overall COVID-19–associated hospitalizations reported to Los Angeles County Department of Public Health that were potentially misclassified as caused by COVID-19 because of incidentally detected virus in patients who were hospitalized for unrelated reasons. In their study, they reviewed medical records from a randomly selected subset of hospital discharges with a clinical diagnosis of COVID-19 to determine whether a clinical diagnosis of COVID-19 was warranted. Among 618 patients, COVID-19 was deemed incidental to the reason for hospitalization in 12% (95% CI, 9%-16%) of admissions.

Incidental viral detection is more common during periods of high case prevalence and when case presentations overlap with nonclassic COVID symptoms.³ Incidental viral detection also occurs when broad testing of asymptomatic patients is instituted prior to admission, procedures, or high-risk medical therapies. Residual postinfectious shedding and false-positive results may further falsely increase case counts. The clinical and infection control implications of detectable virus is further complicated by vaccination, which leads to milder forms of the infection with less capacity for transmission.⁴

Why is establishing an overestimation COVID-19 hospitalization important? First, if misclassification leads to an overestimate of the number of hospitalizations caused by COVID-19, public health restrictions might be increased to protect overloading acute care sites when such measures are unnecessary, resulting in unintended social and economic fallouts.⁵ Second, healthcare resource allocation depends on accurate estimates of disease burden—overestimation of COVID-19–related hospitalization can lead to misallocation of scarce resources, including personnel, equipment, and medication to units or hospitals.⁶ Relatedly, cancelling of “nonurgent” tests, procedures, and clinic visits to reallocate resources to COVID-19–related care delays diagnosis and treatment of potentially serious illnesses. Last, overattributing hospitalizations due to COVID-19, particularly in patients who are now fully vaccinated, may lead researchers to underestimate the efficacy of vaccination efforts on the individual and population level, especially in the era of evolving variant strains.

How could this research change future practice? As the authors astutely state, the purpose of the investigation is not to alter practice on the individual patient level, but rather to help public health officials to make better decisions. One solution (similar to census adjustment) based on future research would be to potentially apply a corrective factor to “adjust” COVID-19 hospitalizations downward to explicitly account for the recognition that some proportion of patients hospitalized with COVID-19 were not actually hospitalized because of COVID-19.

Although vaccination continues to be highly successful at curbing the pandemic, transmission of COVID-19 persists due to gaps in vaccination and emergence of variants. Therefore, continued ongoing vigilance for disease burden, specifically focused on the most vulnerable aspects of the health care system—acute care centers—is critical to informing optimal public health restrictions and resource allocation.

Throughout North America, hospitalizations and deaths due to SARS-CoV-2 have fallen substantially due to the rapid roll-out of COVID-19 vaccines. Despite this monumental success, however, transmission of the virus will unfortunately persist for the foreseeable future due to a variety of factors, including incomplete population vaccination, emergence of variants, and increased exposures as social and economic activity return to normal.¹ Therefore, it is of critical importance to continue to track the burden of COVID-19 by region. Specifically, the incidence of hospitalizations due to COVID-19 will be a key metric, as highlighted by Tsai et al² in this issue of the Journal of Hospital Medicine.

Tsai et al² explored the challenge of accurately determining the burden of hospitalization due to COVID-19, focusing on the potential for misclassification leading to overestimations. They rigorously evaluated the proportion of overall COVID-19–associated hospitalizations reported to Los Angeles County Department of Public Health that were potentially misclassified as caused by COVID-19 because of incidentally detected virus in patients who were hospitalized for unrelated reasons. In their study, they reviewed medical records from a randomly selected subset of hospital discharges with a clinical diagnosis of COVID-19 to determine whether a clinical diagnosis of COVID-19 was warranted. Among 618 patients, COVID-19 was deemed incidental to the reason for hospitalization in 12% (95% CI, 9%-16%) of admissions.

Incidental viral detection is more common during periods of high case prevalence and when case presentations overlap with nonclassic COVID symptoms.³ Incidental viral detection also occurs when broad testing of asymptomatic patients is instituted prior to admission, procedures, or high-risk medical therapies. Residual postinfectious shedding and false-positive results may further falsely increase case counts. The clinical and infection control implications of detectable virus is further complicated by vaccination, which leads to milder forms of the infection with less capacity for transmission.⁴

Why is establishing an overestimation COVID-19 hospitalization important? First, if misclassification leads to an overestimate of the number of hospitalizations caused by COVID-19, public health restrictions might be increased to protect overloading acute care sites when such measures are unnecessary, resulting in unintended social and economic fallouts.⁵ Second, healthcare resource allocation depends on accurate estimates of disease burden—overestimation of COVID-19–related hospitalization can lead to misallocation of scarce resources, including personnel, equipment, and medication to units or hospitals.⁶ Relatedly, cancelling of “nonurgent” tests, procedures, and clinic visits to reallocate resources to COVID-19–related care delays diagnosis and treatment of potentially serious illnesses. Last, overattributing hospitalizations due to COVID-19, particularly in patients who are now fully vaccinated, may lead researchers to underestimate the efficacy of vaccination efforts on the individual and population level, especially in the era of evolving variant strains.

How could this research change future practice? As the authors astutely state, the purpose of the investigation is not to alter practice on the individual patient level, but rather to help public health officials to make better decisions. One solution (similar to census adjustment) based on future research would be to potentially apply a corrective factor to “adjust” COVID-19 hospitalizations downward to explicitly account for the recognition that some proportion of patients hospitalized with COVID-19 were not actually hospitalized because of COVID-19.

Although vaccination continues to be highly successful at curbing the pandemic, transmission of COVID-19 persists due to gaps in vaccination and emergence of variants. Therefore, continued ongoing vigilance for disease burden, specifically focused on the most vulnerable aspects of the health care system—acute care centers—is critical to informing optimal public health restrictions and resource allocation.

Throughout North America, hospitalizations and deaths due to SARS-CoV-2 have fallen substantially due to the rapid roll-out of COVID-19 vaccines. Despite this monumental success, however, transmission of the virus will unfortunately persist for the foreseeable future due to a variety of factors, including incomplete population vaccination, emergence of variants, and increased exposures as social and economic activity return to normal.¹ Therefore, it is of critical importance to continue to track the burden of COVID-19 by region. Specifically, the incidence of hospitalizations due to COVID-19 will be a key metric, as highlighted by Tsai et al² in this issue of the Journal of Hospital Medicine.

Tsai et al² explored the challenge of accurately determining the burden of hospitalization due to COVID-19, focusing on the potential for misclassification leading to overestimations. They rigorously evaluated the proportion of overall COVID-19–associated hospitalizations reported to Los Angeles County Department of Public Health that were potentially misclassified as caused by COVID-19 because of incidentally detected virus in patients who were hospitalized for unrelated reasons. In their study, they reviewed medical records from a randomly selected subset of hospital discharges with a clinical diagnosis of COVID-19 to determine whether a clinical diagnosis of COVID-19 was warranted. Among 618 patients, COVID-19 was deemed incidental to the reason for hospitalization in 12% (95% CI, 9%-16%) of admissions.

Incidental viral detection is more common during periods of high case prevalence and when case presentations overlap with nonclassic COVID symptoms.³ Incidental viral detection also occurs when broad testing of asymptomatic patients is instituted prior to admission, procedures, or high-risk medical therapies. Residual postinfectious shedding and false-positive results may further falsely increase case counts. The clinical and infection control implications of detectable virus is further complicated by vaccination, which leads to milder forms of the infection with less capacity for transmission.⁴

Why is establishing an overestimation COVID-19 hospitalization important? First, if misclassification leads to an overestimate of the number of hospitalizations caused by COVID-19, public health restrictions might be increased to protect overloading acute care sites when such measures are unnecessary, resulting in unintended social and economic fallouts.⁵ Second, healthcare resource allocation depends on accurate estimates of disease burden—overestimation of COVID-19–related hospitalization can lead to misallocation of scarce resources, including personnel, equipment, and medication to units or hospitals.⁶ Relatedly, cancelling of “nonurgent” tests, procedures, and clinic visits to reallocate resources to COVID-19–related care delays diagnosis and treatment of potentially serious illnesses. Last, overattributing hospitalizations due to COVID-19, particularly in patients who are now fully vaccinated, may lead researchers to underestimate the efficacy of vaccination efforts on the individual and population level, especially in the era of evolving variant strains.

How could this research change future practice? As the authors astutely state, the purpose of the investigation is not to alter practice on the individual patient level, but rather to help public health officials to make better decisions. One solution (similar to census adjustment) based on future research would be to potentially apply a corrective factor to “adjust” COVID-19 hospitalizations downward to explicitly account for the recognition that some proportion of patients hospitalized with COVID-19 were not actually hospitalized because of COVID-19.

Although vaccination continues to be highly successful at curbing the pandemic, transmission of COVID-19 persists due to gaps in vaccination and emergence of variants. Therefore, continued ongoing vigilance for disease burden, specifically focused on the most vulnerable aspects of the health care system—acute care centers—is critical to informing optimal public health restrictions and resource allocation.

“Being a role model is the most powerful form of educating.”

—John Wooden

The typical approach to faculty development in education often emphasizes specific teaching skills, such as rounding and teaching styles, providing expectations, and giving feedback. Before these strategies can be applied, however, we must first take note that memorable and influential physicians share common practices of compassionate, person-centered care. Role models are important in professional, character, and career development.¹ Role modeling compassionate patient care gains learners’ respect and engagement, and, ideally, inspires them to grow as people and physicians. An often-overlooked foundation of improving as a medical educator is working to improve our bedside interactions and role modeling compassionate care.

As new roles and promotions draw us away from clinical commitments and toward administrative work, it is easy to become disconnected from the value of clinical medicine. We risk unintentionally perpetuating a hidden curriculum that undervalues humanistic care when we do not explicitly endorse empathic values and behaviors. Exemplary teaching physicians respect patients, care for their well-being, and consider the big picture.² Next time you are rounding, remember the importance of bedside patient interactions.

With that in mind, here are three key strategies to consider for effective physician-patient interactions.

1. Start strong: It is crucial to get off to a good start by leading with respect and kindness. Knocking and pausing before entering the patient’s hospital room shows you remember that they are in vulnerable positions, with little privacy. Smiling warmly when greeting patients shows you are happy to see them. Greet them using their preferred honorific and introduce yourself and your team each day. Ask whether it’s okay to mute the television, but remember to turn the volume back up when leaving. Convey warmth with appropriate touch, consider small acts to make the patient more comfortable, and, when possible, sit at a patient’s eye level.

2. Show empathy: Be patient and remind yourself that hospitalized patients and their families are often in the most difficult times of their lives. In addition to being in vulnerable positions, patients are often lonely and anxious. Humanistic physicians get to know patients as people and beyond their medical illness by talking about nonmedical topics.³ Ask about their family, their pets, memorable moments in their lives, sports teams, favorite shows, and how they pass the time while hospitalized. Are there any photos they would like to share with you? Ask, too, before you leave the room whether they need you to reach something for them. Use humor thoughtfully, and always with kindness. Demonstrate humility about your own abilities, and what you know and do not know about the patient’s diagnoses, and their lived experience.

3. Strive for trustworthiness: Advocate for the patient and show them and your learners that you care. Make shared decisions when straying from guideline-directed care. Aim for trustworthiness; patients’ distrust is an adaptive response to how they have experienced healthcare, so while you do not have to take distrust personally, you should take addressing it as a personal obligation. Be aware of your own privilege, and that how patients perceive you is a reflection of how they have experienced the world, including other clinicians. Model vulnerability, including showing appropriate sadness when there is bad news to report and acknowledging grief.

Being a better clinical teacher starts with being a better doctor. Role modeling compassionate and person-centered care is a cornerstone of being an exceptional clinical teacher.

We gratefully acknowledge SHM’s Physician-in-Training Committee, whose support made this collaboration possible.

“Being a role model is the most powerful form of educating.”

—John Wooden

The typical approach to faculty development in education often emphasizes specific teaching skills, such as rounding and teaching styles, providing expectations, and giving feedback. Before these strategies can be applied, however, we must first take note that memorable and influential physicians share common practices of compassionate, person-centered care. Role models are important in professional, character, and career development.¹ Role modeling compassionate patient care gains learners’ respect and engagement, and, ideally, inspires them to grow as people and physicians. An often-overlooked foundation of improving as a medical educator is working to improve our bedside interactions and role modeling compassionate care.

As new roles and promotions draw us away from clinical commitments and toward administrative work, it is easy to become disconnected from the value of clinical medicine. We risk unintentionally perpetuating a hidden curriculum that undervalues humanistic care when we do not explicitly endorse empathic values and behaviors. Exemplary teaching physicians respect patients, care for their well-being, and consider the big picture.² Next time you are rounding, remember the importance of bedside patient interactions.

With that in mind, here are three key strategies to consider for effective physician-patient interactions.

1. Start strong: It is crucial to get off to a good start by leading with respect and kindness. Knocking and pausing before entering the patient’s hospital room shows you remember that they are in vulnerable positions, with little privacy. Smiling warmly when greeting patients shows you are happy to see them. Greet them using their preferred honorific and introduce yourself and your team each day. Ask whether it’s okay to mute the television, but remember to turn the volume back up when leaving. Convey warmth with appropriate touch, consider small acts to make the patient more comfortable, and, when possible, sit at a patient’s eye level.

2. Show empathy: Be patient and remind yourself that hospitalized patients and their families are often in the most difficult times of their lives. In addition to being in vulnerable positions, patients are often lonely and anxious. Humanistic physicians get to know patients as people and beyond their medical illness by talking about nonmedical topics.³ Ask about their family, their pets, memorable moments in their lives, sports teams, favorite shows, and how they pass the time while hospitalized. Are there any photos they would like to share with you? Ask, too, before you leave the room whether they need you to reach something for them. Use humor thoughtfully, and always with kindness. Demonstrate humility about your own abilities, and what you know and do not know about the patient’s diagnoses, and their lived experience.

3. Strive for trustworthiness: Advocate for the patient and show them and your learners that you care. Make shared decisions when straying from guideline-directed care. Aim for trustworthiness; patients’ distrust is an adaptive response to how they have experienced healthcare, so while you do not have to take distrust personally, you should take addressing it as a personal obligation. Be aware of your own privilege, and that how patients perceive you is a reflection of how they have experienced the world, including other clinicians. Model vulnerability, including showing appropriate sadness when there is bad news to report and acknowledging grief.

Being a better clinical teacher starts with being a better doctor. Role modeling compassionate and person-centered care is a cornerstone of being an exceptional clinical teacher.

We gratefully acknowledge SHM’s Physician-in-Training Committee, whose support made this collaboration possible.

“Being a role model is the most powerful form of educating.”

—John Wooden

The typical approach to faculty development in education often emphasizes specific teaching skills, such as rounding and teaching styles, providing expectations, and giving feedback. Before these strategies can be applied, however, we must first take note that memorable and influential physicians share common practices of compassionate, person-centered care. Role models are important in professional, character, and career development.¹ Role modeling compassionate patient care gains learners’ respect and engagement, and, ideally, inspires them to grow as people and physicians. An often-overlooked foundation of improving as a medical educator is working to improve our bedside interactions and role modeling compassionate care.

As new roles and promotions draw us away from clinical commitments and toward administrative work, it is easy to become disconnected from the value of clinical medicine. We risk unintentionally perpetuating a hidden curriculum that undervalues humanistic care when we do not explicitly endorse empathic values and behaviors. Exemplary teaching physicians respect patients, care for their well-being, and consider the big picture.² Next time you are rounding, remember the importance of bedside patient interactions.

With that in mind, here are three key strategies to consider for effective physician-patient interactions.

1. Start strong: It is crucial to get off to a good start by leading with respect and kindness. Knocking and pausing before entering the patient’s hospital room shows you remember that they are in vulnerable positions, with little privacy. Smiling warmly when greeting patients shows you are happy to see them. Greet them using their preferred honorific and introduce yourself and your team each day. Ask whether it’s okay to mute the television, but remember to turn the volume back up when leaving. Convey warmth with appropriate touch, consider small acts to make the patient more comfortable, and, when possible, sit at a patient’s eye level.

2. Show empathy: Be patient and remind yourself that hospitalized patients and their families are often in the most difficult times of their lives. In addition to being in vulnerable positions, patients are often lonely and anxious. Humanistic physicians get to know patients as people and beyond their medical illness by talking about nonmedical topics.³ Ask about their family, their pets, memorable moments in their lives, sports teams, favorite shows, and how they pass the time while hospitalized. Are there any photos they would like to share with you? Ask, too, before you leave the room whether they need you to reach something for them. Use humor thoughtfully, and always with kindness. Demonstrate humility about your own abilities, and what you know and do not know about the patient’s diagnoses, and their lived experience.

3. Strive for trustworthiness: Advocate for the patient and show them and your learners that you care. Make shared decisions when straying from guideline-directed care. Aim for trustworthiness; patients’ distrust is an adaptive response to how they have experienced healthcare, so while you do not have to take distrust personally, you should take addressing it as a personal obligation. Be aware of your own privilege, and that how patients perceive you is a reflection of how they have experienced the world, including other clinicians. Model vulnerability, including showing appropriate sadness when there is bad news to report and acknowledging grief.

Being a better clinical teacher starts with being a better doctor. Role modeling compassionate and person-centered care is a cornerstone of being an exceptional clinical teacher.

We gratefully acknowledge SHM’s Physician-in-Training Committee, whose support made this collaboration possible.

August is a month that we traditionally reserved for rest and recovery. But unfortunately, there seems to be little of either as we recover from COVID-19, deal with the care that has been delayed, try to understand issues of health inequity, and manage our hybrid reimbursement landscape. So let’s set those issues aside for a bit and get back to science.

In this month’s cover stories, we can read about some astounding accomplishments. A fantastic study comes from Dana-Farber Cancer Institute, Boston, where researchers found 900 colorectal cancers from nurses who had participated in the long-running Nurse’s Health Studies. The researchers completed a whole-exome sequence on both normal and tumor tissue and then linked findings to the nutritional information contained in the Health Studies. With this information, they connected a tumor-associated mutation to the ingestion of red meat, which may suggest a causal link for the known association between red meat and CRC.

AGA has published a detailed clinical practice update about endoscopic management of postsurgical complications after bariatric/metabolic surgery. Bariatric therapy is an area in which gastroenterologists should play an increasingly prominent role, in conjunction with our surgical and metabolic colleagues.

Finally, read about a novel oral therapy that may provide substantial relief for celiac patients. This randomized trial of a transglutaminase inhibitor was published in the New England Journal of Medicine and may provide new hope for this difficult condition.

October marks the end of my term as Editor-in-Chief. Megan Adams, MD, JD, MSc, will take over and provide insights and opinions beyond my past missives. I thank Christopher Palmer and the excellent Frontline staff who find topics and compose articles for us. Finally, the publication department at the American Gastroenterological Association is unparalleled, led by Erin Landis with Jillian Schweitzer managing the GI & Hepatology News area. I am fortunate to return to the AGA Governing Board as Secretary/Treasurer and work with our new president, John Inadomi, as well as Tom Serena, a great friend and AGA CEO.

John I Allen, MD, MBA, AGAF
Editor in Chief

August is a month that we traditionally reserved for rest and recovery. But unfortunately, there seems to be little of either as we recover from COVID-19, deal with the care that has been delayed, try to understand issues of health inequity, and manage our hybrid reimbursement landscape. So let’s set those issues aside for a bit and get back to science.

In this month’s cover stories, we can read about some astounding accomplishments. A fantastic study comes from Dana-Farber Cancer Institute, Boston, where researchers found 900 colorectal cancers from nurses who had participated in the long-running Nurse’s Health Studies. The researchers completed a whole-exome sequence on both normal and tumor tissue and then linked findings to the nutritional information contained in the Health Studies. With this information, they connected a tumor-associated mutation to the ingestion of red meat, which may suggest a causal link for the known association between red meat and CRC.

AGA has published a detailed clinical practice update about endoscopic management of postsurgical complications after bariatric/metabolic surgery. Bariatric therapy is an area in which gastroenterologists should play an increasingly prominent role, in conjunction with our surgical and metabolic colleagues.

Finally, read about a novel oral therapy that may provide substantial relief for celiac patients. This randomized trial of a transglutaminase inhibitor was published in the New England Journal of Medicine and may provide new hope for this difficult condition.

October marks the end of my term as Editor-in-Chief. Megan Adams, MD, JD, MSc, will take over and provide insights and opinions beyond my past missives. I thank Christopher Palmer and the excellent Frontline staff who find topics and compose articles for us. Finally, the publication department at the American Gastroenterological Association is unparalleled, led by Erin Landis with Jillian Schweitzer managing the GI & Hepatology News area. I am fortunate to return to the AGA Governing Board as Secretary/Treasurer and work with our new president, John Inadomi, as well as Tom Serena, a great friend and AGA CEO.

John I Allen, MD, MBA, AGAF
Editor in Chief

August is a month that we traditionally reserved for rest and recovery. But unfortunately, there seems to be little of either as we recover from COVID-19, deal with the care that has been delayed, try to understand issues of health inequity, and manage our hybrid reimbursement landscape. So let’s set those issues aside for a bit and get back to science.

In this month’s cover stories, we can read about some astounding accomplishments. A fantastic study comes from Dana-Farber Cancer Institute, Boston, where researchers found 900 colorectal cancers from nurses who had participated in the long-running Nurse’s Health Studies. The researchers completed a whole-exome sequence on both normal and tumor tissue and then linked findings to the nutritional information contained in the Health Studies. With this information, they connected a tumor-associated mutation to the ingestion of red meat, which may suggest a causal link for the known association between red meat and CRC.

AGA has published a detailed clinical practice update about endoscopic management of postsurgical complications after bariatric/metabolic surgery. Bariatric therapy is an area in which gastroenterologists should play an increasingly prominent role, in conjunction with our surgical and metabolic colleagues.

Finally, read about a novel oral therapy that may provide substantial relief for celiac patients. This randomized trial of a transglutaminase inhibitor was published in the New England Journal of Medicine and may provide new hope for this difficult condition.

October marks the end of my term as Editor-in-Chief. Megan Adams, MD, JD, MSc, will take over and provide insights and opinions beyond my past missives. I thank Christopher Palmer and the excellent Frontline staff who find topics and compose articles for us. Finally, the publication department at the American Gastroenterological Association is unparalleled, led by Erin Landis with Jillian Schweitzer managing the GI & Hepatology News area. I am fortunate to return to the AGA Governing Board as Secretary/Treasurer and work with our new president, John Inadomi, as well as Tom Serena, a great friend and AGA CEO.

John I Allen, MD, MBA, AGAF
Editor in Chief

The seroconversion was highest in patients with CML with 75% and observed in 5/6 (83%) of CML patients receiving imatinib that compare favorably to the total group with 58% of seroconversions. Interestingly patients treated with pegylated interferon also had a a high response with 88% (7/8).

Another recent publication by Harrington et al Br J Hem 2021, Jun 3 ahead or print, confirmed and extending the previous data by evaluating humoral and cellular immune responses after a first injection of BNT162b2 vaccine in 16 patients with CML. 87.5% patients have a seroconversion and 93.3% developed a T cell response. These responses are seen in contrast to patients with lymphoid hematological malignancies where the responses have been significantly lower.

The main goal of the treatment for chronic phase CML is to stop the progression to more advanced phased of the disease such as blast phase, where treatments are limited and there are no consensus in the treatment approach. In a recent publication by Saxena et al. J Hematol Oncol. 2021 Jun 15 the authors reported the outcomes of patients with BP-CML treated with different regimens that include a combination therapy of tyrosine kinase inhibitor (TKI) with intensive chemotherapy (IC) or hypomethylating agent (HMA) as well as  TKI or IC alone. Response rates were similar between patients treated with IC + TKI and HMA + TKI. When compared to treatment with TKI alone, treatment with IC/HMA + TKI was superior (CRi 57.5% vs 33.9%), as well as higher complete cytogenetic response rate (45% vs 10.7%) and more patients proceeding to ASCT (32.5% vs 10.7%). The results were even better when using a second generation TKI in combination with IC or HMA with a favorable EFS and OS compared to TKI alone.

The seroconversion was highest in patients with CML with 75% and observed in 5/6 (83%) of CML patients receiving imatinib that compare favorably to the total group with 58% of seroconversions. Interestingly patients treated with pegylated interferon also had a a high response with 88% (7/8).

Another recent publication by Harrington et al Br J Hem 2021, Jun 3 ahead or print, confirmed and extending the previous data by evaluating humoral and cellular immune responses after a first injection of BNT162b2 vaccine in 16 patients with CML. 87.5% patients have a seroconversion and 93.3% developed a T cell response. These responses are seen in contrast to patients with lymphoid hematological malignancies where the responses have been significantly lower.

The main goal of the treatment for chronic phase CML is to stop the progression to more advanced phased of the disease such as blast phase, where treatments are limited and there are no consensus in the treatment approach. In a recent publication by Saxena et al. J Hematol Oncol. 2021 Jun 15 the authors reported the outcomes of patients with BP-CML treated with different regimens that include a combination therapy of tyrosine kinase inhibitor (TKI) with intensive chemotherapy (IC) or hypomethylating agent (HMA) as well as  TKI or IC alone. Response rates were similar between patients treated with IC + TKI and HMA + TKI. When compared to treatment with TKI alone, treatment with IC/HMA + TKI was superior (CRi 57.5% vs 33.9%), as well as higher complete cytogenetic response rate (45% vs 10.7%) and more patients proceeding to ASCT (32.5% vs 10.7%). The results were even better when using a second generation TKI in combination with IC or HMA with a favorable EFS and OS compared to TKI alone.

The seroconversion was highest in patients with CML with 75% and observed in 5/6 (83%) of CML patients receiving imatinib that compare favorably to the total group with 58% of seroconversions. Interestingly patients treated with pegylated interferon also had a a high response with 88% (7/8).

Another recent publication by Harrington et al Br J Hem 2021, Jun 3 ahead or print, confirmed and extending the previous data by evaluating humoral and cellular immune responses after a first injection of BNT162b2 vaccine in 16 patients with CML. 87.5% patients have a seroconversion and 93.3% developed a T cell response. These responses are seen in contrast to patients with lymphoid hematological malignancies where the responses have been significantly lower.

The main goal of the treatment for chronic phase CML is to stop the progression to more advanced phased of the disease such as blast phase, where treatments are limited and there are no consensus in the treatment approach. In a recent publication by Saxena et al. J Hematol Oncol. 2021 Jun 15 the authors reported the outcomes of patients with BP-CML treated with different regimens that include a combination therapy of tyrosine kinase inhibitor (TKI) with intensive chemotherapy (IC) or hypomethylating agent (HMA) as well as  TKI or IC alone. Response rates were similar between patients treated with IC + TKI and HMA + TKI. When compared to treatment with TKI alone, treatment with IC/HMA + TKI was superior (CRi 57.5% vs 33.9%), as well as higher complete cytogenetic response rate (45% vs 10.7%) and more patients proceeding to ASCT (32.5% vs 10.7%). The results were even better when using a second generation TKI in combination with IC or HMA with a favorable EFS and OS compared to TKI alone.

Q2. Correct answer: A. CT scan. 
 
Rationale  
Given the change in bowel habits, colonoscopy in indicated to evaluate for inflammation. Anorectal manometry is helpful in evaluating sphincter function. Endoanal ultrasound can identify anal sphincter defects in the internal or external anal sphincter. Digital rectal exam is important in evaluating the anal area for skin tags, fissures, or scar. Digital exam can evaluate for resting anal sphincter tone and squeeze, pelvic floor descent and strength of the pelvic floor muscles. CT is unlikely to contribute to the evaluation of a functional disorder.  
 
Reference  
Bharucha AE et al. Gastroenterology. 2006 Apr;130(5):1510-8.

Q2. Correct answer: A. CT scan. 
 
Rationale  
Given the change in bowel habits, colonoscopy in indicated to evaluate for inflammation. Anorectal manometry is helpful in evaluating sphincter function. Endoanal ultrasound can identify anal sphincter defects in the internal or external anal sphincter. Digital rectal exam is important in evaluating the anal area for skin tags, fissures, or scar. Digital exam can evaluate for resting anal sphincter tone and squeeze, pelvic floor descent and strength of the pelvic floor muscles. CT is unlikely to contribute to the evaluation of a functional disorder.  
 
Reference  
Bharucha AE et al. Gastroenterology. 2006 Apr;130(5):1510-8.

Q2. Correct answer: A. CT scan. 
 
Rationale  
Given the change in bowel habits, colonoscopy in indicated to evaluate for inflammation. Anorectal manometry is helpful in evaluating sphincter function. Endoanal ultrasound can identify anal sphincter defects in the internal or external anal sphincter. Digital rectal exam is important in evaluating the anal area for skin tags, fissures, or scar. Digital exam can evaluate for resting anal sphincter tone and squeeze, pelvic floor descent and strength of the pelvic floor muscles. CT is unlikely to contribute to the evaluation of a functional disorder.  
 
Reference  
Bharucha AE et al. Gastroenterology. 2006 Apr;130(5):1510-8.

Q1. Correct answer: C. Esophagogastric junction outflow obstruction.  
 
Rationale  
Recent studies recognized the role of medications in inducing esophageal motor disorders. Opiates have been shown to be associated with esophagogastric junction outflow obstruction, achalasia (not type 1), and other hypercontractile esophageal abnormalities.  
 
Reference  
Camilleri M et al. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1338-49.

Q1. Correct answer: C. Esophagogastric junction outflow obstruction.  
 
Rationale  
Recent studies recognized the role of medications in inducing esophageal motor disorders. Opiates have been shown to be associated with esophagogastric junction outflow obstruction, achalasia (not type 1), and other hypercontractile esophageal abnormalities.  
 
Reference  
Camilleri M et al. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1338-49.

Q1. Correct answer: C. Esophagogastric junction outflow obstruction.  
 
Rationale  
Recent studies recognized the role of medications in inducing esophageal motor disorders. Opiates have been shown to be associated with esophagogastric junction outflow obstruction, achalasia (not type 1), and other hypercontractile esophageal abnormalities.  
 
Reference  
Camilleri M et al. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1338-49.

Small increases in daily physical activity are associated with a boost in 1-year survival in patients with heart failure and coronary disease who received an implantable cardioverter defibrillator (ICD), new research suggests.

“Our study looked at how much exercise was necessary for a better outcome in patients with prior ICD implantation and, for every 10 minutes of exercise, we saw a 1% reduction in the likelihood of death or hospitalization, which is a pretty profound impact on outcome for just a small amount of additional physical activity per day,” lead author Brett Atwater, MD, told this news organization.

“These improvements were achieved outside of a formal cardiac rehabilitation program, suggesting that the benefits of increased physical activity obtained in cardiac rehabilitation programs may also be achievable at home,” he said.

Cardiac rehabilitation (CR) programs have been shown to improve short- and long-term outcomes in patients with heart failure (HF) but continue to be underutilized, especially by women, the elderly, and minorities. Home-based CR could help overcome this limitation but the science behind it is relatively new, noted Dr. Atwater, director of electrophysiology and electrophysiology research, Inova Heart and Vascular Institute, Fairfax, Va.

As reported in Circulation Cardiovascular Quality and Outcomes, the study involved 41,731 Medicare beneficiaries (mean age, 73.5 years) who received an ICD from 2014 to 2016.

ICD heart rate and activity sensor measurements were used to establish a personalized physical activity (PA) threshold for each patient in the first 3 weeks after ICD implantation. Thereafter, the ICD logged PA when the personalized PA threshold was exceeded. The mean baseline PA level was 128.9 minutes/day.

At 3 years’ follow-up, one-quarter of the patients had died and half had been hospitalized for HF. Of the total population, only 3.2% participated in CR.

Compared with nonparticipants, CR participants were more likely to be White (91.0% versus 87.3%), male (75.5% versus 72.2%), and to have diabetes (48.8% versus 44.1%), ischemic heart disease (91.4% versus 82.1%), or congestive heart failure (90.4% versus 83.4%).

CR participants attended a median of 24 sessions, during which time daily PA increased by a mean of 9.7 minutes per day. During the same time, PA decreased by a mean of 1.0 minute per day in non-CR participants (P < .001).

PA levels remained “relatively constant” for the first 36 months of follow-up among CR participants before showing a steep decline, whereas levels gradually declined throughout follow-up among nonparticipants, with a median annual change of –4.5 min/day.

In adjusted analysis, every 10 minutes of increased daily PA was associated with a 1.1% reduced risk for death (hazard ratio, 0.989; 95% confidence interval, 0.979-0.996) and a 1% reduced risk for HF hospitalization (HR, 0.99; 95% CI, 0.986-0.995) at 1-year follow-up (P < .001).

After propensity score was used to match CR participants with nonparticipants by demographic characteristics, comorbidities, and baseline PA level, CR participants had a significantly lower risk for death at 1 year (HR, 0.76; 95% CI, 0.69-0.85). This difference in risk remained at 2- and 3-year follow-ups.

However, when the researchers further adjusted for change in PA during CR or the same time period after device implantation, no differences in mortality were found between CR participants and nonparticipants at 1 year (HR, 1.00; 95% CI, 0.82-1.21) or at 2 or 3 years.

The risk for HF hospitalization did not differ between the two groups in either propensity score model.

Unlike wearable devices, implanted devices “don’t give that type of feedback to patients regarding PA levels – only to providers – and it will be interesting to discover whether providing feedback to patients can motivate them to do more physical activity,” Dr. Atwater commented.

The team is currently enrolling patients in a follow-up trial, in which patients will be given feedback from their ICD “to move these data from an interesting observation to something that can drive outcomes,” he said.

Commenting for this news organization, Melissa Tracy, MD, Rush University Medical Center, Chicago, said the study reiterates the “profound” underutilization of CR.

“Only about 3% of patients who should have qualified for cardiac rehabilitation actually attended, which is startling considering that it has class 1A level of evidence supporting its use,” she said.

Dr. Tracy, who is also a member of the American College of Cardiology’s Prevention of Cardiovascular Disease Section Leadership Council, described the study as “another notch in the belt of positive outcomes supporting the need for cardiac rehabilitation” and emphasizing the importance of a home-based alternative.

“One of the reasons women, minorities, and older patients don’t go to cardiac rehabilitation is they have to get there, rely on someone to drive them, or they have other responsibilities – especially women, who are often primary caretakers of others,” she said. “For women and men, the pressure to get back to work and support their families means they don’t have the luxury to go to cardiac rehabilitation.”

Dr. Tracy noted that home-based CR is covered by CMS until the end of 2021. “An important take-home is for providers and patients to understand that they do have a home-based option,” she stated.

Limitations of the study are that only 24% of patients were women, only 6% were Black, and the results might not be generalizable to patients younger than 65 years, note Dr. Atwater and colleagues. Also, previous implantation might have protected the cohort from experiencing arrhythmic death, and it remains unclear if similar results would be obtained in patients without a previous ICD.

This research was funded through the unrestricted Abbott Medical-Duke Health Strategic Alliance Research Grant. Dr. Atwater receives significant research support from Boston Scientific and Abbott Medical, and modest honoraria from Abbott Medical, Medtronic, and Biotronik. Coauthor disclosures are listed in the paper. Dr. Tracy has created cardiac prevention programs with Virtual Health Partners (VHP) and owns the intellectual property and consults with VHP but receives no monetary compensation.
 

A version of this article first appeared on Medscape.com.

Small increases in daily physical activity are associated with a boost in 1-year survival in patients with heart failure and coronary disease who received an implantable cardioverter defibrillator (ICD), new research suggests.

“Our study looked at how much exercise was necessary for a better outcome in patients with prior ICD implantation and, for every 10 minutes of exercise, we saw a 1% reduction in the likelihood of death or hospitalization, which is a pretty profound impact on outcome for just a small amount of additional physical activity per day,” lead author Brett Atwater, MD, told this news organization.

“These improvements were achieved outside of a formal cardiac rehabilitation program, suggesting that the benefits of increased physical activity obtained in cardiac rehabilitation programs may also be achievable at home,” he said.

Cardiac rehabilitation (CR) programs have been shown to improve short- and long-term outcomes in patients with heart failure (HF) but continue to be underutilized, especially by women, the elderly, and minorities. Home-based CR could help overcome this limitation but the science behind it is relatively new, noted Dr. Atwater, director of electrophysiology and electrophysiology research, Inova Heart and Vascular Institute, Fairfax, Va.

As reported in Circulation Cardiovascular Quality and Outcomes, the study involved 41,731 Medicare beneficiaries (mean age, 73.5 years) who received an ICD from 2014 to 2016.

ICD heart rate and activity sensor measurements were used to establish a personalized physical activity (PA) threshold for each patient in the first 3 weeks after ICD implantation. Thereafter, the ICD logged PA when the personalized PA threshold was exceeded. The mean baseline PA level was 128.9 minutes/day.

At 3 years’ follow-up, one-quarter of the patients had died and half had been hospitalized for HF. Of the total population, only 3.2% participated in CR.

Compared with nonparticipants, CR participants were more likely to be White (91.0% versus 87.3%), male (75.5% versus 72.2%), and to have diabetes (48.8% versus 44.1%), ischemic heart disease (91.4% versus 82.1%), or congestive heart failure (90.4% versus 83.4%).

CR participants attended a median of 24 sessions, during which time daily PA increased by a mean of 9.7 minutes per day. During the same time, PA decreased by a mean of 1.0 minute per day in non-CR participants (P < .001).

PA levels remained “relatively constant” for the first 36 months of follow-up among CR participants before showing a steep decline, whereas levels gradually declined throughout follow-up among nonparticipants, with a median annual change of –4.5 min/day.

In adjusted analysis, every 10 minutes of increased daily PA was associated with a 1.1% reduced risk for death (hazard ratio, 0.989; 95% confidence interval, 0.979-0.996) and a 1% reduced risk for HF hospitalization (HR, 0.99; 95% CI, 0.986-0.995) at 1-year follow-up (P < .001).

After propensity score was used to match CR participants with nonparticipants by demographic characteristics, comorbidities, and baseline PA level, CR participants had a significantly lower risk for death at 1 year (HR, 0.76; 95% CI, 0.69-0.85). This difference in risk remained at 2- and 3-year follow-ups.

However, when the researchers further adjusted for change in PA during CR or the same time period after device implantation, no differences in mortality were found between CR participants and nonparticipants at 1 year (HR, 1.00; 95% CI, 0.82-1.21) or at 2 or 3 years.

The risk for HF hospitalization did not differ between the two groups in either propensity score model.

Unlike wearable devices, implanted devices “don’t give that type of feedback to patients regarding PA levels – only to providers – and it will be interesting to discover whether providing feedback to patients can motivate them to do more physical activity,” Dr. Atwater commented.

The team is currently enrolling patients in a follow-up trial, in which patients will be given feedback from their ICD “to move these data from an interesting observation to something that can drive outcomes,” he said.

Commenting for this news organization, Melissa Tracy, MD, Rush University Medical Center, Chicago, said the study reiterates the “profound” underutilization of CR.

“Only about 3% of patients who should have qualified for cardiac rehabilitation actually attended, which is startling considering that it has class 1A level of evidence supporting its use,” she said.

Dr. Tracy, who is also a member of the American College of Cardiology’s Prevention of Cardiovascular Disease Section Leadership Council, described the study as “another notch in the belt of positive outcomes supporting the need for cardiac rehabilitation” and emphasizing the importance of a home-based alternative.

“One of the reasons women, minorities, and older patients don’t go to cardiac rehabilitation is they have to get there, rely on someone to drive them, or they have other responsibilities – especially women, who are often primary caretakers of others,” she said. “For women and men, the pressure to get back to work and support their families means they don’t have the luxury to go to cardiac rehabilitation.”

Dr. Tracy noted that home-based CR is covered by CMS until the end of 2021. “An important take-home is for providers and patients to understand that they do have a home-based option,” she stated.

Limitations of the study are that only 24% of patients were women, only 6% were Black, and the results might not be generalizable to patients younger than 65 years, note Dr. Atwater and colleagues. Also, previous implantation might have protected the cohort from experiencing arrhythmic death, and it remains unclear if similar results would be obtained in patients without a previous ICD.

This research was funded through the unrestricted Abbott Medical-Duke Health Strategic Alliance Research Grant. Dr. Atwater receives significant research support from Boston Scientific and Abbott Medical, and modest honoraria from Abbott Medical, Medtronic, and Biotronik. Coauthor disclosures are listed in the paper. Dr. Tracy has created cardiac prevention programs with Virtual Health Partners (VHP) and owns the intellectual property and consults with VHP but receives no monetary compensation.
 

A version of this article first appeared on Medscape.com.

Small increases in daily physical activity are associated with a boost in 1-year survival in patients with heart failure and coronary disease who received an implantable cardioverter defibrillator (ICD), new research suggests.

“Our study looked at how much exercise was necessary for a better outcome in patients with prior ICD implantation and, for every 10 minutes of exercise, we saw a 1% reduction in the likelihood of death or hospitalization, which is a pretty profound impact on outcome for just a small amount of additional physical activity per day,” lead author Brett Atwater, MD, told this news organization.

“These improvements were achieved outside of a formal cardiac rehabilitation program, suggesting that the benefits of increased physical activity obtained in cardiac rehabilitation programs may also be achievable at home,” he said.

Cardiac rehabilitation (CR) programs have been shown to improve short- and long-term outcomes in patients with heart failure (HF) but continue to be underutilized, especially by women, the elderly, and minorities. Home-based CR could help overcome this limitation but the science behind it is relatively new, noted Dr. Atwater, director of electrophysiology and electrophysiology research, Inova Heart and Vascular Institute, Fairfax, Va.

As reported in Circulation Cardiovascular Quality and Outcomes, the study involved 41,731 Medicare beneficiaries (mean age, 73.5 years) who received an ICD from 2014 to 2016.

ICD heart rate and activity sensor measurements were used to establish a personalized physical activity (PA) threshold for each patient in the first 3 weeks after ICD implantation. Thereafter, the ICD logged PA when the personalized PA threshold was exceeded. The mean baseline PA level was 128.9 minutes/day.

At 3 years’ follow-up, one-quarter of the patients had died and half had been hospitalized for HF. Of the total population, only 3.2% participated in CR.

Compared with nonparticipants, CR participants were more likely to be White (91.0% versus 87.3%), male (75.5% versus 72.2%), and to have diabetes (48.8% versus 44.1%), ischemic heart disease (91.4% versus 82.1%), or congestive heart failure (90.4% versus 83.4%).

CR participants attended a median of 24 sessions, during which time daily PA increased by a mean of 9.7 minutes per day. During the same time, PA decreased by a mean of 1.0 minute per day in non-CR participants (P < .001).

PA levels remained “relatively constant” for the first 36 months of follow-up among CR participants before showing a steep decline, whereas levels gradually declined throughout follow-up among nonparticipants, with a median annual change of –4.5 min/day.

In adjusted analysis, every 10 minutes of increased daily PA was associated with a 1.1% reduced risk for death (hazard ratio, 0.989; 95% confidence interval, 0.979-0.996) and a 1% reduced risk for HF hospitalization (HR, 0.99; 95% CI, 0.986-0.995) at 1-year follow-up (P < .001).

After propensity score was used to match CR participants with nonparticipants by demographic characteristics, comorbidities, and baseline PA level, CR participants had a significantly lower risk for death at 1 year (HR, 0.76; 95% CI, 0.69-0.85). This difference in risk remained at 2- and 3-year follow-ups.

However, when the researchers further adjusted for change in PA during CR or the same time period after device implantation, no differences in mortality were found between CR participants and nonparticipants at 1 year (HR, 1.00; 95% CI, 0.82-1.21) or at 2 or 3 years.

The risk for HF hospitalization did not differ between the two groups in either propensity score model.

Unlike wearable devices, implanted devices “don’t give that type of feedback to patients regarding PA levels – only to providers – and it will be interesting to discover whether providing feedback to patients can motivate them to do more physical activity,” Dr. Atwater commented.

The team is currently enrolling patients in a follow-up trial, in which patients will be given feedback from their ICD “to move these data from an interesting observation to something that can drive outcomes,” he said.

Commenting for this news organization, Melissa Tracy, MD, Rush University Medical Center, Chicago, said the study reiterates the “profound” underutilization of CR.

“Only about 3% of patients who should have qualified for cardiac rehabilitation actually attended, which is startling considering that it has class 1A level of evidence supporting its use,” she said.

Dr. Tracy, who is also a member of the American College of Cardiology’s Prevention of Cardiovascular Disease Section Leadership Council, described the study as “another notch in the belt of positive outcomes supporting the need for cardiac rehabilitation” and emphasizing the importance of a home-based alternative.

“One of the reasons women, minorities, and older patients don’t go to cardiac rehabilitation is they have to get there, rely on someone to drive them, or they have other responsibilities – especially women, who are often primary caretakers of others,” she said. “For women and men, the pressure to get back to work and support their families means they don’t have the luxury to go to cardiac rehabilitation.”

Dr. Tracy noted that home-based CR is covered by CMS until the end of 2021. “An important take-home is for providers and patients to understand that they do have a home-based option,” she stated.

Limitations of the study are that only 24% of patients were women, only 6% were Black, and the results might not be generalizable to patients younger than 65 years, note Dr. Atwater and colleagues. Also, previous implantation might have protected the cohort from experiencing arrhythmic death, and it remains unclear if similar results would be obtained in patients without a previous ICD.

This research was funded through the unrestricted Abbott Medical-Duke Health Strategic Alliance Research Grant. Dr. Atwater receives significant research support from Boston Scientific and Abbott Medical, and modest honoraria from Abbott Medical, Medtronic, and Biotronik. Coauthor disclosures are listed in the paper. Dr. Tracy has created cardiac prevention programs with Virtual Health Partners (VHP) and owns the intellectual property and consults with VHP but receives no monetary compensation.
 

A version of this article first appeared on Medscape.com.

Insulin pump technology has been available since the 1970s. Innovation in insulin pumps has had significant impact on the management of diabetes mellitus (DM). In recent years, automated insulin pump technology (AIP) has proven to be a safe and effective way to treat DM. It has been studied mostly in highly organized randomized controlled trials (RCTs) in younger populations with type 1 DM (T1DM).^1-3

One of the challenges in DM care has always been the wide variations in daily plasma glucose concentration that often cause major swings of hyperglycemia and hypoglycemia. Extreme variations in blood glucose have also been linked to adverse outcomes, including poor micro- and macrovascular outcomes.^4,5 AIP technology is a hybrid closed-loop system that attempts to solve this problem by adjusting insulin delivery in response to real-time glucose information from a continuous glucose monitor (CGM). Glucose measurements are sent to the insulin pump in real time, which uses a specialized algorithm to determine whether insulin delivery should be up-titrated, down-titrated, or suspended.⁶

Several studies have shown that AIP technology reduces glucose variability and increases the percentage of time within the optimal glucose range.^1-3,7 Its safety is especially indicated for patients with long-standing DM who often have hypoglycemia unawareness and recurrent episodes of hypoglycemia.⁷ Safety is the major advantage of the hybrid closed-loop system as long duration of DM makes patients particularly prone to emergency department (ED) visits and hospitalizations for severe hypoglycemia.⁸ Recurrent hypoglycemia also is associated with increased cardiovascular mortality in epidemiologic studies.⁹

Safety was the primary endpoint in the pivotal trial in a multicenter clinical study where 124 participants (mean age, 37.8 years; DM duration, 21.7 years; hemoglobin A_1c [HbA_1c], 7.4%) were monitored for 3 months while using a hybrid closed-loop pump, similar to the one used in our study.¹⁰ Remarkably, there were no device-related episodes of severe hypoglycemia or ketoacidosis. There was even a small but significant difference in HbA_1c (7.4% at baseline, 6.9% at 3 months) and of the time in target range measured by CGM from 66.7% at baseline to 72.2% at 3 months). However, the mean age of the population studied was young (mean age, 37.8 years). It is unclear how these results would translate for a population of older patients with T1DM. Moreover, use of AIP systems have not been systematically tested outside of carefully controlled studies, as it would be in middle-aged veterans followed in outpatient US Department of Veterans Affairs (VA) clinics. Such an approach in the context of optimal glucose monitoring combined with use of structured DM education can significantly reduce impaired awareness of hypoglycemia in patients with T1DM of long duration.¹¹

This is the first study to assess the feasibility of AIP technology in a real-world population of older veterans with T1DM in terms of safety and acceptability, because AIP has just recently become available for patient care in the Veterans Health Administration (VHA). This group of patients is of particular interest because they have been largely overlooked in earlier studies. They represent an older population with long-standing DM where hypoglycemia unawareness is often recurrent and incapacitating. In addition, long-standing DM makes optimal glycemic control mandatory to prevent microvascular complications.

Methods

In this retrospective review study,, we examined available data in patients with T1DM at the Malcom Randall VA Medical Center diabetes clinic in Gainesville, Florida, between March and December of 2018 who agreed to use AIP. In this clinic, the AIP system was offered to T1DM patients when the 4-year warranty of a previous insulin pump expired, they had frequent hypoglycemic events, or they were on multiple daily injections and were proficient with carbohydrate counting and adjusting insulin doses and willing to use an insulin pump. Veterans were trained on AIP use by a certified diabetes educator and pump trainer in sessions that lasted 2 to 4 hours depending on previous experience with AIP. Institutional review board approval was obtained at the University of Florida. 

Demographic and clinical data before and after the initiation of AIP were collected, including standard insulin pump/CGM information for the Medtronic 670G and Guardian 3 Sensor AIPs. Several variables were evaluated, including age, gender, year of DM diagnosis, time of initiation of AIP, HbA_1c, download data (percentage sensor wear, time in automated mode and manual mode, time in/above/below range, bolus information, insulin use, average sensor blood glucose, average meter blood glucose, pump settings), weight, body mass index (BMI), glucose meter information, history of hypoglycemia unawareness.

The primary outcome for this study was safety as assessed by percentage of time below target range on glucose sensor (time below target range is defined as < 70 mg/dL). We also addressed the secondary endpoint of efficacy as the percentage of time in-range defined as blood glucose per glucose sensor of 70 mg/dL to 180 mg/dL (efficacy), percentage of glucose sensor wear, and HbA_1c.

Statistics

Comparisons of changes in continuous variables between groups were performed by an analysis of covariance (ANCOVA), adjusting for baseline levels. Fisher exact test (χ²) and unpaired t test were used to compare group differences at baseline for categorical and continuous variables, respectively, while Wilcoxon rank sum test was used for nonnormally distributed values. Changes in continuous measures within the same group were tested by paired t test or Wilcoxon matched-pairs signed rank test when applicable. Analyses were performed using Stata 11.0.

Results

Thirty-seven veterans with T1DM using AIPs in 2018 were evaluated at baseline and at follow up visits (Tables 1 and 2). Time frame for follow-up was approximately 3 months, although there was some variation. Of note, the mean weight and BMI corresponded to mostly lean individuals, consistent with the diagnosis of T1DM.

Time below target range hypoglycemia (sensor glucose < 70 mg/dL) remained low at each follow-up visit (both 1.5%). Percentage of time in automated mode increased from first to second follow-up visit after initiation of AIP (41% vs 53%, P = .06). Percentage of sensor wear numerically increased from first to second follow-up visit (75% vs 85%, P = .39), same as time in range, defined as sensor glucose 70 to 180 mg/dL, from first to second follow-up visit (70% vs 73%, P = .09). Time above range, defined as sensor glucose > 180 mg/dL, demonstrated a strong trend toward decreasing between follow-up appointments (29% to 25%; P = .09). HbA_1c decreased from 7.6% to 7.3% (P = .005).

About half of the patients (18 of 37) reported hypoglycemia unawareness before the initiation of the 670G AIP. On follow-up visit 61% (11 of 18) reported significant improvement in awareness. Of the remaining 18 patients who reported normal awareness before automated mode, 17% (3 of 18) described a new onset unawareness.

Discussion

This study evaluated the safety of adopting a new DM technology in the real world of an outpatient VA clinic. To the best of our knowledge, this is the first study evaluating the use of AIP specifically in a population of middle-aged veterans with longstanding T1DM. After a mean 7 months of follow-up, participants accepted AIP use as evidenced by increased sensor wear over time and experienced improvements in DM measures that indicate successful use (ie, time in automated mode, which represents reduced glycemic variability). These results show success of an AIP approach in a demographically older group of patients.

AIP has been shown to have positive effects on glycemic control such as time in target glucose range (goal ≥ 70%). In our relatively small pilot study, there was trend for an improvement in the time in range from the first to second clinical follow-up visit, suggesting true patient involvement with the use of the device. Studies involving overall younger cohorts have proved that AIP technology is safe and efficacious for outpatient management of T1DM.^7,10,12,13 However, they were all conducted under the safety of a research setting, and trials enrolled a younger population believed to adapt with more ease to this new technology. Tauschmann and colleagues performed a multicenter, parallel randomized controlled trial that compared hybrid closed-loop AIP therapy with sensor-augmented pump therapy in patients with suboptimal T1DM control.¹² Results showed that the hybrid closed-loop system increased the time that the glucose concentration was within the target range (70-180 mg/dL) from 54% in the sensor-augmented pump group to 65% on the closed-loop system (P < .001). A small but significant improvement in HBA_1c (from 8.0 -7.4%) and low rates of hypoglycemia (2.6% of time below 70 mg/dL) were also noted.¹²

A similar benefit was observed in a 2019 landmark study by Brown and colleagues of 168 patients with T1DM at 7 university medical centers who were treated for 6 months with either a closed-loop system (closed-loop group) or a sensor-augmented pump (control group) in a parallel-group, unblinded, randomized trial study.¹³ Mean (SD) time in the target range increased in the closed-loop group from 61% (17) at baseline to 71% (12) during the 6 months. HbA_1c decreased from 7.4 to 7.1% and time ≤ 70 mg/dL was just 1.6%. However, only 13% of patients were aged ≥ 40 years in the study by Tauschmann and colleagues, and mean age was 33 years in the Brown and colleagues study.^12,13 In contrast, the mean (SD) age in our study was 59 (14) years. Our pilot study also showed comparable, or somewhat better results, as mean time in target range was 72%, HbA_1c was 7.3%, and time ≤ 70 mg/dL was just 1.5%.

Limitations

There are some limitations to our study. The small sample size and single-center nature prevent generalization. Also, the veteran population cannot be extrapolated to other populations. For instance, the majority of the patients in this study were male.

Conclusions

We report that an AIP approach for patients with long-standing T1DM is well accepted and engages patients into monitoring their blood sugars and achieving better glycemic control. This was achieved with minimal hypoglycemia in a population where often hypoglycemia unawareness makes DM care a challenge. Future studies within the VHA are needed to fully assess the long-term benefits and cost-effectiveness of this technology in veterans.

Insulin pump technology has been available since the 1970s. Innovation in insulin pumps has had significant impact on the management of diabetes mellitus (DM). In recent years, automated insulin pump technology (AIP) has proven to be a safe and effective way to treat DM. It has been studied mostly in highly organized randomized controlled trials (RCTs) in younger populations with type 1 DM (T1DM).^1-3

One of the challenges in DM care has always been the wide variations in daily plasma glucose concentration that often cause major swings of hyperglycemia and hypoglycemia. Extreme variations in blood glucose have also been linked to adverse outcomes, including poor micro- and macrovascular outcomes.^4,5 AIP technology is a hybrid closed-loop system that attempts to solve this problem by adjusting insulin delivery in response to real-time glucose information from a continuous glucose monitor (CGM). Glucose measurements are sent to the insulin pump in real time, which uses a specialized algorithm to determine whether insulin delivery should be up-titrated, down-titrated, or suspended.⁶

Several studies have shown that AIP technology reduces glucose variability and increases the percentage of time within the optimal glucose range.^1-3,7 Its safety is especially indicated for patients with long-standing DM who often have hypoglycemia unawareness and recurrent episodes of hypoglycemia.⁷ Safety is the major advantage of the hybrid closed-loop system as long duration of DM makes patients particularly prone to emergency department (ED) visits and hospitalizations for severe hypoglycemia.⁸ Recurrent hypoglycemia also is associated with increased cardiovascular mortality in epidemiologic studies.⁹

Safety was the primary endpoint in the pivotal trial in a multicenter clinical study where 124 participants (mean age, 37.8 years; DM duration, 21.7 years; hemoglobin A_1c [HbA_1c], 7.4%) were monitored for 3 months while using a hybrid closed-loop pump, similar to the one used in our study.¹⁰ Remarkably, there were no device-related episodes of severe hypoglycemia or ketoacidosis. There was even a small but significant difference in HbA_1c (7.4% at baseline, 6.9% at 3 months) and of the time in target range measured by CGM from 66.7% at baseline to 72.2% at 3 months). However, the mean age of the population studied was young (mean age, 37.8 years). It is unclear how these results would translate for a population of older patients with T1DM. Moreover, use of AIP systems have not been systematically tested outside of carefully controlled studies, as it would be in middle-aged veterans followed in outpatient US Department of Veterans Affairs (VA) clinics. Such an approach in the context of optimal glucose monitoring combined with use of structured DM education can significantly reduce impaired awareness of hypoglycemia in patients with T1DM of long duration.¹¹

This is the first study to assess the feasibility of AIP technology in a real-world population of older veterans with T1DM in terms of safety and acceptability, because AIP has just recently become available for patient care in the Veterans Health Administration (VHA). This group of patients is of particular interest because they have been largely overlooked in earlier studies. They represent an older population with long-standing DM where hypoglycemia unawareness is often recurrent and incapacitating. In addition, long-standing DM makes optimal glycemic control mandatory to prevent microvascular complications.

Methods

In this retrospective review study,, we examined available data in patients with T1DM at the Malcom Randall VA Medical Center diabetes clinic in Gainesville, Florida, between March and December of 2018 who agreed to use AIP. In this clinic, the AIP system was offered to T1DM patients when the 4-year warranty of a previous insulin pump expired, they had frequent hypoglycemic events, or they were on multiple daily injections and were proficient with carbohydrate counting and adjusting insulin doses and willing to use an insulin pump. Veterans were trained on AIP use by a certified diabetes educator and pump trainer in sessions that lasted 2 to 4 hours depending on previous experience with AIP. Institutional review board approval was obtained at the University of Florida. 

Demographic and clinical data before and after the initiation of AIP were collected, including standard insulin pump/CGM information for the Medtronic 670G and Guardian 3 Sensor AIPs. Several variables were evaluated, including age, gender, year of DM diagnosis, time of initiation of AIP, HbA_1c, download data (percentage sensor wear, time in automated mode and manual mode, time in/above/below range, bolus information, insulin use, average sensor blood glucose, average meter blood glucose, pump settings), weight, body mass index (BMI), glucose meter information, history of hypoglycemia unawareness.

The primary outcome for this study was safety as assessed by percentage of time below target range on glucose sensor (time below target range is defined as < 70 mg/dL). We also addressed the secondary endpoint of efficacy as the percentage of time in-range defined as blood glucose per glucose sensor of 70 mg/dL to 180 mg/dL (efficacy), percentage of glucose sensor wear, and HbA_1c.

Statistics

Comparisons of changes in continuous variables between groups were performed by an analysis of covariance (ANCOVA), adjusting for baseline levels. Fisher exact test (χ²) and unpaired t test were used to compare group differences at baseline for categorical and continuous variables, respectively, while Wilcoxon rank sum test was used for nonnormally distributed values. Changes in continuous measures within the same group were tested by paired t test or Wilcoxon matched-pairs signed rank test when applicable. Analyses were performed using Stata 11.0.

Results

Thirty-seven veterans with T1DM using AIPs in 2018 were evaluated at baseline and at follow up visits (Tables 1 and 2). Time frame for follow-up was approximately 3 months, although there was some variation. Of note, the mean weight and BMI corresponded to mostly lean individuals, consistent with the diagnosis of T1DM.

Time below target range hypoglycemia (sensor glucose < 70 mg/dL) remained low at each follow-up visit (both 1.5%). Percentage of time in automated mode increased from first to second follow-up visit after initiation of AIP (41% vs 53%, P = .06). Percentage of sensor wear numerically increased from first to second follow-up visit (75% vs 85%, P = .39), same as time in range, defined as sensor glucose 70 to 180 mg/dL, from first to second follow-up visit (70% vs 73%, P = .09). Time above range, defined as sensor glucose > 180 mg/dL, demonstrated a strong trend toward decreasing between follow-up appointments (29% to 25%; P = .09). HbA_1c decreased from 7.6% to 7.3% (P = .005).

About half of the patients (18 of 37) reported hypoglycemia unawareness before the initiation of the 670G AIP. On follow-up visit 61% (11 of 18) reported significant improvement in awareness. Of the remaining 18 patients who reported normal awareness before automated mode, 17% (3 of 18) described a new onset unawareness.

Discussion

This study evaluated the safety of adopting a new DM technology in the real world of an outpatient VA clinic. To the best of our knowledge, this is the first study evaluating the use of AIP specifically in a population of middle-aged veterans with longstanding T1DM. After a mean 7 months of follow-up, participants accepted AIP use as evidenced by increased sensor wear over time and experienced improvements in DM measures that indicate successful use (ie, time in automated mode, which represents reduced glycemic variability). These results show success of an AIP approach in a demographically older group of patients.

AIP has been shown to have positive effects on glycemic control such as time in target glucose range (goal ≥ 70%). In our relatively small pilot study, there was trend for an improvement in the time in range from the first to second clinical follow-up visit, suggesting true patient involvement with the use of the device. Studies involving overall younger cohorts have proved that AIP technology is safe and efficacious for outpatient management of T1DM.^7,10,12,13 However, they were all conducted under the safety of a research setting, and trials enrolled a younger population believed to adapt with more ease to this new technology. Tauschmann and colleagues performed a multicenter, parallel randomized controlled trial that compared hybrid closed-loop AIP therapy with sensor-augmented pump therapy in patients with suboptimal T1DM control.¹² Results showed that the hybrid closed-loop system increased the time that the glucose concentration was within the target range (70-180 mg/dL) from 54% in the sensor-augmented pump group to 65% on the closed-loop system (P < .001). A small but significant improvement in HBA_1c (from 8.0 -7.4%) and low rates of hypoglycemia (2.6% of time below 70 mg/dL) were also noted.¹²

A similar benefit was observed in a 2019 landmark study by Brown and colleagues of 168 patients with T1DM at 7 university medical centers who were treated for 6 months with either a closed-loop system (closed-loop group) or a sensor-augmented pump (control group) in a parallel-group, unblinded, randomized trial study.¹³ Mean (SD) time in the target range increased in the closed-loop group from 61% (17) at baseline to 71% (12) during the 6 months. HbA_1c decreased from 7.4 to 7.1% and time ≤ 70 mg/dL was just 1.6%. However, only 13% of patients were aged ≥ 40 years in the study by Tauschmann and colleagues, and mean age was 33 years in the Brown and colleagues study.^12,13 In contrast, the mean (SD) age in our study was 59 (14) years. Our pilot study also showed comparable, or somewhat better results, as mean time in target range was 72%, HbA_1c was 7.3%, and time ≤ 70 mg/dL was just 1.5%.

Limitations

There are some limitations to our study. The small sample size and single-center nature prevent generalization. Also, the veteran population cannot be extrapolated to other populations. For instance, the majority of the patients in this study were male.

Conclusions

We report that an AIP approach for patients with long-standing T1DM is well accepted and engages patients into monitoring their blood sugars and achieving better glycemic control. This was achieved with minimal hypoglycemia in a population where often hypoglycemia unawareness makes DM care a challenge. Future studies within the VHA are needed to fully assess the long-term benefits and cost-effectiveness of this technology in veterans.

Insulin pump technology has been available since the 1970s. Innovation in insulin pumps has had significant impact on the management of diabetes mellitus (DM). In recent years, automated insulin pump technology (AIP) has proven to be a safe and effective way to treat DM. It has been studied mostly in highly organized randomized controlled trials (RCTs) in younger populations with type 1 DM (T1DM).^1-3

One of the challenges in DM care has always been the wide variations in daily plasma glucose concentration that often cause major swings of hyperglycemia and hypoglycemia. Extreme variations in blood glucose have also been linked to adverse outcomes, including poor micro- and macrovascular outcomes.^4,5 AIP technology is a hybrid closed-loop system that attempts to solve this problem by adjusting insulin delivery in response to real-time glucose information from a continuous glucose monitor (CGM). Glucose measurements are sent to the insulin pump in real time, which uses a specialized algorithm to determine whether insulin delivery should be up-titrated, down-titrated, or suspended.⁶

Several studies have shown that AIP technology reduces glucose variability and increases the percentage of time within the optimal glucose range.^1-3,7 Its safety is especially indicated for patients with long-standing DM who often have hypoglycemia unawareness and recurrent episodes of hypoglycemia.⁷ Safety is the major advantage of the hybrid closed-loop system as long duration of DM makes patients particularly prone to emergency department (ED) visits and hospitalizations for severe hypoglycemia.⁸ Recurrent hypoglycemia also is associated with increased cardiovascular mortality in epidemiologic studies.⁹

Safety was the primary endpoint in the pivotal trial in a multicenter clinical study where 124 participants (mean age, 37.8 years; DM duration, 21.7 years; hemoglobin A_1c [HbA_1c], 7.4%) were monitored for 3 months while using a hybrid closed-loop pump, similar to the one used in our study.¹⁰ Remarkably, there were no device-related episodes of severe hypoglycemia or ketoacidosis. There was even a small but significant difference in HbA_1c (7.4% at baseline, 6.9% at 3 months) and of the time in target range measured by CGM from 66.7% at baseline to 72.2% at 3 months). However, the mean age of the population studied was young (mean age, 37.8 years). It is unclear how these results would translate for a population of older patients with T1DM. Moreover, use of AIP systems have not been systematically tested outside of carefully controlled studies, as it would be in middle-aged veterans followed in outpatient US Department of Veterans Affairs (VA) clinics. Such an approach in the context of optimal glucose monitoring combined with use of structured DM education can significantly reduce impaired awareness of hypoglycemia in patients with T1DM of long duration.¹¹

This is the first study to assess the feasibility of AIP technology in a real-world population of older veterans with T1DM in terms of safety and acceptability, because AIP has just recently become available for patient care in the Veterans Health Administration (VHA). This group of patients is of particular interest because they have been largely overlooked in earlier studies. They represent an older population with long-standing DM where hypoglycemia unawareness is often recurrent and incapacitating. In addition, long-standing DM makes optimal glycemic control mandatory to prevent microvascular complications.

Methods

In this retrospective review study,, we examined available data in patients with T1DM at the Malcom Randall VA Medical Center diabetes clinic in Gainesville, Florida, between March and December of 2018 who agreed to use AIP. In this clinic, the AIP system was offered to T1DM patients when the 4-year warranty of a previous insulin pump expired, they had frequent hypoglycemic events, or they were on multiple daily injections and were proficient with carbohydrate counting and adjusting insulin doses and willing to use an insulin pump. Veterans were trained on AIP use by a certified diabetes educator and pump trainer in sessions that lasted 2 to 4 hours depending on previous experience with AIP. Institutional review board approval was obtained at the University of Florida. 

Demographic and clinical data before and after the initiation of AIP were collected, including standard insulin pump/CGM information for the Medtronic 670G and Guardian 3 Sensor AIPs. Several variables were evaluated, including age, gender, year of DM diagnosis, time of initiation of AIP, HbA_1c, download data (percentage sensor wear, time in automated mode and manual mode, time in/above/below range, bolus information, insulin use, average sensor blood glucose, average meter blood glucose, pump settings), weight, body mass index (BMI), glucose meter information, history of hypoglycemia unawareness.

The primary outcome for this study was safety as assessed by percentage of time below target range on glucose sensor (time below target range is defined as < 70 mg/dL). We also addressed the secondary endpoint of efficacy as the percentage of time in-range defined as blood glucose per glucose sensor of 70 mg/dL to 180 mg/dL (efficacy), percentage of glucose sensor wear, and HbA_1c.

Statistics

Comparisons of changes in continuous variables between groups were performed by an analysis of covariance (ANCOVA), adjusting for baseline levels. Fisher exact test (χ²) and unpaired t test were used to compare group differences at baseline for categorical and continuous variables, respectively, while Wilcoxon rank sum test was used for nonnormally distributed values. Changes in continuous measures within the same group were tested by paired t test or Wilcoxon matched-pairs signed rank test when applicable. Analyses were performed using Stata 11.0.

Results

Thirty-seven veterans with T1DM using AIPs in 2018 were evaluated at baseline and at follow up visits (Tables 1 and 2). Time frame for follow-up was approximately 3 months, although there was some variation. Of note, the mean weight and BMI corresponded to mostly lean individuals, consistent with the diagnosis of T1DM.

Time below target range hypoglycemia (sensor glucose < 70 mg/dL) remained low at each follow-up visit (both 1.5%). Percentage of time in automated mode increased from first to second follow-up visit after initiation of AIP (41% vs 53%, P = .06). Percentage of sensor wear numerically increased from first to second follow-up visit (75% vs 85%, P = .39), same as time in range, defined as sensor glucose 70 to 180 mg/dL, from first to second follow-up visit (70% vs 73%, P = .09). Time above range, defined as sensor glucose > 180 mg/dL, demonstrated a strong trend toward decreasing between follow-up appointments (29% to 25%; P = .09). HbA_1c decreased from 7.6% to 7.3% (P = .005).

About half of the patients (18 of 37) reported hypoglycemia unawareness before the initiation of the 670G AIP. On follow-up visit 61% (11 of 18) reported significant improvement in awareness. Of the remaining 18 patients who reported normal awareness before automated mode, 17% (3 of 18) described a new onset unawareness.

Discussion

This study evaluated the safety of adopting a new DM technology in the real world of an outpatient VA clinic. To the best of our knowledge, this is the first study evaluating the use of AIP specifically in a population of middle-aged veterans with longstanding T1DM. After a mean 7 months of follow-up, participants accepted AIP use as evidenced by increased sensor wear over time and experienced improvements in DM measures that indicate successful use (ie, time in automated mode, which represents reduced glycemic variability). These results show success of an AIP approach in a demographically older group of patients.

AIP has been shown to have positive effects on glycemic control such as time in target glucose range (goal ≥ 70%). In our relatively small pilot study, there was trend for an improvement in the time in range from the first to second clinical follow-up visit, suggesting true patient involvement with the use of the device. Studies involving overall younger cohorts have proved that AIP technology is safe and efficacious for outpatient management of T1DM.^7,10,12,13 However, they were all conducted under the safety of a research setting, and trials enrolled a younger population believed to adapt with more ease to this new technology. Tauschmann and colleagues performed a multicenter, parallel randomized controlled trial that compared hybrid closed-loop AIP therapy with sensor-augmented pump therapy in patients with suboptimal T1DM control.¹² Results showed that the hybrid closed-loop system increased the time that the glucose concentration was within the target range (70-180 mg/dL) from 54% in the sensor-augmented pump group to 65% on the closed-loop system (P < .001). A small but significant improvement in HBA_1c (from 8.0 -7.4%) and low rates of hypoglycemia (2.6% of time below 70 mg/dL) were also noted.¹²

A similar benefit was observed in a 2019 landmark study by Brown and colleagues of 168 patients with T1DM at 7 university medical centers who were treated for 6 months with either a closed-loop system (closed-loop group) or a sensor-augmented pump (control group) in a parallel-group, unblinded, randomized trial study.¹³ Mean (SD) time in the target range increased in the closed-loop group from 61% (17) at baseline to 71% (12) during the 6 months. HbA_1c decreased from 7.4 to 7.1% and time ≤ 70 mg/dL was just 1.6%. However, only 13% of patients were aged ≥ 40 years in the study by Tauschmann and colleagues, and mean age was 33 years in the Brown and colleagues study.^12,13 In contrast, the mean (SD) age in our study was 59 (14) years. Our pilot study also showed comparable, or somewhat better results, as mean time in target range was 72%, HbA_1c was 7.3%, and time ≤ 70 mg/dL was just 1.5%.

Limitations

There are some limitations to our study. The small sample size and single-center nature prevent generalization. Also, the veteran population cannot be extrapolated to other populations. For instance, the majority of the patients in this study were male.

Conclusions

We report that an AIP approach for patients with long-standing T1DM is well accepted and engages patients into monitoring their blood sugars and achieving better glycemic control. This was achieved with minimal hypoglycemia in a population where often hypoglycemia unawareness makes DM care a challenge. Future studies within the VHA are needed to fully assess the long-term benefits and cost-effectiveness of this technology in veterans.